Identity
- Trade Name
- Visgeneer FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- 25x2pcs FDA UDI
- Model / Reference
- 30G I FDA UDI
- Description
- 25x2pcs FDA UDI
Identifiers
- Catalog Number
- https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# FDA UDI
- Primary DI / UDI-DI
- 04712558762342 FDA UDI
- 510(k) Number
- K222034 FDA UDI
- FDA Product Code
- QRK FDA UDI
- GMDN Term
- Blood lancet, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood lancet, single-use
Visgeneer by Visgeneer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K222034 also covers:
- EasyTouch — MHC Medical Products
- Members Mark — MHC Medical Products
- Members Mark — MHC Medical Products
- Members Mark — MHC Medical Products
- STAT Medical Devices — Stat Medical Devices
- STAT Medical Devices — Stat Medical Devices
- Vive Precision — VIVE HEALTH LLC
- RightLance — Visgeneer, Inc.
- Members Mark — Walmart Stores
- Members Mark — Walmart Stores
- Members Mark — Walmart Stores
- CareSoft — i-SENS, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Visgeneer, Inc.
Sources (1)
- FDA UDI 99476a11-d359-4b2f-8596-325fbfc26f0b 35 fields · synced May 30, 2026